Resp-O2

GUDID 00840117305663

Resp-O2 Heat Moisture Exchanger and B/V Filter (HMEF) 1000, CO2 Port, Adult

DYNAREX CORPORATION

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 00840117305663
• NIH Device Record Key: b23b0188-4b14-4385-9a14-9fb5af6050e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2
• Version Model Number: 30100
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117305656 [Primary]
GS1	00840117305663 [Package]; Contains: 00840117305656; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132709

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-30
• Device Publish Date: 2021-04-22

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